4.2MM X 13CM 15 DEGREE PRE-BENT LANZA 9391M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-30 for 4.2MM X 13CM 15 DEGREE PRE-BENT LANZA 9391M manufactured by Conmed Corporation.

MAUDE Entry Details

• Report Number: 1017294-2020-00034
• MDR Report Key: 9649318
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2020-01-30
• Date of Report: 2020-02-11
• Date of Event: 2020-01-21
• Date Mfgr Received: 2020-02-07
• Device Manufacturer Date: 2019-07-24
• Date Added to Maude: 2020-01-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS TRACEY WEISELBENTON
• Manufacturer Street: 11311 CONCEPT BLVD
• Manufacturer City: LARGO, FL FL 337734908
• Manufacturer Country: US
• Manufacturer Postal: 337734908
• Manufacturer Phone: 7273995557
• Manufacturer G1: CONMED CORPORATION
• Manufacturer Street: 11311 CONCEPT BLVD
• Manufacturer City: LARGO, FL FL 337734908
• Manufacturer Country: US
• Manufacturer Postal Code: 337734908
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 4.2MM X 13CM 15 DEGREE PRE-BENT LANZA
• Generic Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Product Code: GFA
• Date Received: 2020-01-30
• Model Number: 9391M
• Catalog Number: 9391M
• Lot Number: 1036186
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONMED CORPORATION
• Manufacturer Address: 11311 CONCEPT BLVD LARGO FL 337734908 US 337734908

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-30